One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis

Atrophied Posterior Maxilla Clinical Trial

Official title:

One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03590964
• Other study ID #: CEBD-CU-2018-07-05
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: Mohamed K Hassan, MSc.
• Phone: 01111284444
• Email: dr_mkdentistry[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.

First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring.

Description:

Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.

(A) First group will be subjected to open sinus lift with chin bone graft.

• All cases will undergo surgery under general anesthesia for sinus lift and other surgery under local anesthesia for implant placement .

• Exposure of the anterior wall of maxilla according to standardized surgical approach.

• Open sinus lift and bone graft.

• After 6 months, implant will be drilled and inserted in the recipient site according to standard protocol.

• Loading on implant after 5-6 months.

(B)Second group will be subjected to sinus floor elevation using a bone ring.

• All cases will undergo surgery under local anesthesia for implant placement in the mandibular chin and other surgery under general anesthesia for sinus lift using bone ring with the implant.

• Exposure of the mandibular chin will be done under local anesthesia using a standardized surgical approach.

• Implant will be drilled and inserted in the chin according to standard protocol.

• After 3 months, second surgery under general anesthesia to place the implant and surrounding ring in the atrophied posterior maxilla.

• The bone ring containing the implant allowed to heal for 5-6 months.

Follow up:

• Clinical evaluation will be performed at the first week post-operative.

• Three months post-operative second surgery to put the implant with surrounding ring in atrophied posterior maxilla.

• Five months post-operative to the second surgery, implant will be loaded with the final restoration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.

2. All ages and both sexes were included in this study.

3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

4. Patients with good general condition allowing surgical procedure under general anesthesia.

5. Patients with physical and psychological tolerance.

Exclusion Criteria:

1. Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.

2. Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.

3. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]

Related Conditions & MeSH terms

• Atrophied Posterior Maxilla

Intervention

Procedure:
• Open sinus lift using chin bone graft
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
• Sinus lift using bone ring containing the implant.
Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine-Cairo University.	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Mahesh L, Kurtzman GM, Shukla S. Trephine core: an alternative sinus lift technique. J Oral Implantol. 2014 Jul;40 Spec No:391-6. doi: 10.1563/aaid-joi-D-14-00047. Epub 2014 Mar 12. — View Citation

Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2 — View Citation

Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. Review. — View Citation

Wang PD, Klein S, Kaufman E. One-stage maxillary sinus elevation using a bone core containing a preosseointegrated implant from the mandibular symphysis. Int J Periodontics Restorative Dent. 2002 Oct;22(5):435-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of implant	The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\ no)	One year post-operative.
Secondary	Marginal bone loss around implant	Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter).	one year post operative
Secondary	Pain intensity	Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain.	One month post-operative.
Secondary	Sinus membrane perforation	Perforation of sinus lining will be assessed clinically, (Binary yes\no).	During operation
Secondary	Established bone integration	Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100.	Six months post operative.